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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00394160 |
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
Condition | Intervention | Phase |
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Bronchiolitis |
Drug: MK0476, Montelukast Sodium /Duration of Treatment : 14 Days |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months |
Enrollment: | 12 |
Study Start Date: | December 2004 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 1 Month to 3 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria :
Exclusion Criteria :
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2006_544 |
Study First Received: | October 27, 2006 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00394160 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bronchial Diseases Bronchiolitis Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Hormones Leukotriene Antagonists |
Montelukast Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Bronchitis |
Respiratory System Agents Bronchial Diseases Bronchiolitis Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Pharmacologic Actions |
Leukotriene Antagonists Montelukast Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Lung Diseases Bronchitis |